Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586411
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Comparison of Oxygenation Index and Oxygen Stretch Index
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Oxygenation Index and Oxygen Stretch Index With Mechanical Power Driving Pressure Transpulmonary Pressure and Lung Ultrasound Scores in PARDS Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pediatric acute respiratory distress syndrome pARDS is a heterogeneous clinical syndrome that causes high rates of mortality and morbidity The Pediatric Acute Lung Injury Consensus Conference PALICC guideline recommends using the oxygenation index OI mean airway pressure MAP FiO2 PaO2 for the diagnosis and classification of pediatric ARDS Driving pressure DP is calculated by subtracting PEEP from plateau pressure It is an important determinant of tidal volume in each breath and indirectly reflects lung stress
It is the best parameter associated with mortality and lung injury in many studies In the oxygenation index formula adding driving pressure instead of Pmean may be more useful in evaluating the severity of pARDS In our study we will compare the Oxygenation Stress Index with OI in patients with pARDS We will compare transpulmonary pressure mechanical power lung ultrasound score and other respiratory mechanics which are parameters indicating lung injury
It is the best parameter associated with mortality and lung injury in many studies In the oxygenation index formula adding driving pressure instead of Pmean may be more useful in evaluating the severity of pARDS In our study we will compare the Oxygenation Stress Index with OI in patients with pARDS We will compare transpulmonary pressure mechanical power lung ultrasound score and other respiratory mechanics which are parameters indicating lung injury
Detailed Description:
Pediatric acute respiratory distress syndrome pARDS is a heterogeneous clinical syndrome that causes high rates of mortality and morbidity The Pediatric Acute Lung Injury Consensus Conference PALICC guideline recommends using the oxygenation index OI mean airway pressure MAP FiO2 PaO2 for the diagnosis and classification of pediatric ARDS In recent years studies conducted on adult and pediatric populations have emphasized driving pressure as the most important ventilator parameter associated with mortality Driving pressure DP is calculated by subtracting PEEP from plateau pressure It is an important determinant of tidal volume in each breath and indirectly reflects lung stress Lung stress is directly measured with transpulmonary pressure PL
Mechanical power MP is the amount of energy applied to patients per unit time and its relationship with lung injury has been shown in adult and pediatric studies Another method that shows lung damage is measured noninvasively at the patients bedside It has been validated in many adult pediatric and neonatal studies In an adult study DP was used instead of MAP inspired by the oxygenation index and defined as the Oxygenation stretch index It was emphasized that it can better predict oxygenation and mortality
OI is not used in the ARDS classification in adults Adding airway pressure to the oxygenation equation is very important to standardize the severity of the disease However its effect on patient outcomes has not been determined as much as mean airway pressure plateau and driving pressure In addition no target recommendation has been presented in the PALICC guidelines Plateau pressure is the end-inspiratory pressure and does not have a direct effect on PEEP Since ventilator management is still heterogeneous in pediatric literature in line with the guidelines it seems more logical to use driving pressure which includes both inspiratory pressure and expiratory pressure Within the framework of this information adding driving pressure to the formula instead of Pmean MAP in the oxygenation index may be useful in evaluating both the severity of pARDS and the effectiveness of respiratory dynamics
In our study we will compare the Oxygenation Stretch Index with OI in patients with pARDS We will examine its effects on parameters indicating lung damage respiratory mechanics and patient outcomes
Mechanical power MP is the amount of energy applied to patients per unit time and its relationship with lung injury has been shown in adult and pediatric studies Another method that shows lung damage is measured noninvasively at the patients bedside It has been validated in many adult pediatric and neonatal studies In an adult study DP was used instead of MAP inspired by the oxygenation index and defined as the Oxygenation stretch index It was emphasized that it can better predict oxygenation and mortality
OI is not used in the ARDS classification in adults Adding airway pressure to the oxygenation equation is very important to standardize the severity of the disease However its effect on patient outcomes has not been determined as much as mean airway pressure plateau and driving pressure In addition no target recommendation has been presented in the PALICC guidelines Plateau pressure is the end-inspiratory pressure and does not have a direct effect on PEEP Since ventilator management is still heterogeneous in pediatric literature in line with the guidelines it seems more logical to use driving pressure which includes both inspiratory pressure and expiratory pressure Within the framework of this information adding driving pressure to the formula instead of Pmean MAP in the oxygenation index may be useful in evaluating both the severity of pARDS and the effectiveness of respiratory dynamics
In our study we will compare the Oxygenation Stretch Index with OI in patients with pARDS We will examine its effects on parameters indicating lung damage respiratory mechanics and patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None